BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE ADULT MANUAL RESUSCITATOR

    MDR report key: 1429485 · Received April 2, 2009

    Report

    Report Number
    1217052-2009-00012
    Event Type
    Malfunction
    Date Received
    April 2, 2009
    Date of Event
    March 3, 2009
    Report Date
    March 3, 2009
    Manufacturer
    GALEMED CORPORATION, MANUFACTURED FOR SMITHS MEDICAL ASD, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVALUATION: INVESTIGATION: THIS INVESTIGATION IS BASED ON RETURNED SAMPLES FROM USER FACILITY AND REMAINING INVENTORY OF SUSPECT LOT NUMBER. AFTER NOTIFICATION OF THIS COMPLAINT FOR PART NUMBER 8500, ADULT MANUAL RESUSCITATOR, LOT 070605, THE REMAINING INVENTORY WITH THIS LOT NUMBER WERE EXAMINED FOR DEFLATED OR UNDERINFLATED MASK CUSHIONS. ALL 27 MASKS CUSHIONS APPEARED ADEQUATELY INFLATED. THE 4 ADD'L RESUSCITATOR UNITS WERE RECEIVED FROM THE USER FACILITY. ONE 8500, LOT 070605 (REPORTED LOT), EXP. DATE 2010 (COMPLAINT LOT), ONE 8500, LOT 070719, EXP. DATE 2010-07, (NOT COMPLAINT LOT), ONE 8520, LOT 040419, EXP. DATE 2007-04, (EXPIRED PEDIATRIC UNIT), AND ONE 8528M, LOT 030822, EXP. DATE 2006-08, (EXPIRED INFANT UNIT). ALL 4 UNITS WERE EXAMINED FOR DEFLATED OR UNDERINFLATED MASK CUSHIONS. ALL THE MASKS CUSHIONS APPEARED ADEQUATELY INFLATED. ROOT CAUSE: WE ARE NOT ABLE TO CONFIRM THIS COMPLAINT. BOTH THE PRODUCT RETURNED FROM THE CUSTOMER AND PRODUCT EXAMINED FROM STOCK ALL CONTAINED MASKS WITH ADEQUATELY INFLATED CUSHIONS. THIS REPORT HAS BEEN LOGGED FOR TRENDING.

    Description of Event or Problem · 1

    USER REPORTED THAT THEY HAD AN EVENT THAT WHEN THEY WENT TO USE THE MASK, IT WAS FLAT AND THEY HAD TO OBTAIN ANOTHER PACKAGE. THAT PACKAGE ALSO CONTAINED A FLAT MASK. THEY PULLED ANOTHER PACKAGE TO USE. NO ADVERSE OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE ADULT MANUAL RESUSCITATOR 73 BTM - RESUSCITATOR, PULMONARY, MANUALLY OPERATED SINGLE-USE BTM GALEMED CORPORATION, MANUFACTURED FOR SMITHS MEDICAL ASD, INC. 070605

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR